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The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886860
First Posted: April 23, 2009
Last Update Posted: July 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

Condition Intervention Phase
Cervical Ripening Labor Induction Drug: misoprostol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • success rate of cervical ripening in labor induction [ Time Frame: 12 hours after intervention ]

Secondary Outcome Measures:
  • number of vaginal delivery [ Time Frame: 24 hours ]

Enrollment: 64
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional oral misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters
Drug: misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
Other Name: cytotec
Experimental: titrated oral misoprostol
misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters
Drug: misoprostol
misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
Other Name: cytotec

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 years old or more
  • singleton pregnancy at 37 weeks gestation or more
  • cephalic presentation
  • reassuring fetal heart rate pattern
  • admission for labor induction due to medical or obstetrical conditions
  • bishop score less than 6
  • giving consent and having signed the consent form for this study

Exclusion Criteria:

  • parity more than 3
  • estimated fetal weight more than 3,500 grams
  • non-reassuring fetal heart rate pattern
  • having contraindication for vaginal delivery
  • previous uterine scar
  • suspected abruptio placenta with non-reassuring fetal heart rate pattern
  • abnormal bleeding per vagina, except bloody show
  • PROM
  • having underlying cardiac, hepatic, or renal diseases
  • having history of allergy to misoprostol or prostaglandin analogues
  • cervical dilatation 3 centimeters or more
  • uterine contraction 3 times or more in 10 minute
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886860


Locations
Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Kusol Russameecharoen, MD Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kusol Russameecharoen, MD., Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00886860     History of Changes
Other Study ID Numbers: 091/2552(EC2)
First Submitted: April 22, 2009
First Posted: April 23, 2009
Last Update Posted: July 14, 2010
Last Verified: July 2010

Keywords provided by Mahidol University:
Efficacy
Cervical ripening/Labor induction
Titrated oral misoprostol/Conventional oral misoprostol
Term pregnancy

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics